Traditional Chinese medicine compound quick-acting preparation composition and preparation method thereof

Abstract

The invention discloses a traditional Chinese medicine compound quick-acting preparation composition and a preparation method thereof. The preparation composition is prepared by scientifically compounding cordyceps militaris active peptide obtained by a biotransformation technology, a rhizoma polygonati extract treated by a nano extraction technology, high-purity American ginseng saponin, grape seed procyanidine, lycium barbarum polysaccharide and Chinese chive seed volatile oil. The core innovation of the invention lies in that macromolecular substances in traditional Chinese medicines are converted into micromolecular active components which are easy to absorb through a modern biotechnology, and the bioavailability is improved by utilizing a nanotechnology, so that the bottleneck that the traditional Chinese medicines take effect slowly is broken through. The preparation can quickly activate a plurality of physiological pathways such as NO-cGMP and AMPK, comprehensively regulate blood vessels, nerves and metabolic systems, quickly take effect within 15-30 minutes, has the quick-acting property of western medicines and the safety and multi-target conditioning advantages of traditional Chinese medicines, and can be used for quickly improving circulation, resisting fatigue and enhancing immunity.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine preparation composition technology, specifically to a fast-acting compound traditional Chinese medicine preparation composition and its preparation method. Background Technology

[0002] Traditional Chinese medicine (TCM) compound preparations with rapid onset of action refer to single-dosage form drugs formulated from two or more active ingredients of TCM (or a combination of TCM and Western medicine) in a fixed ratio, characterized by rapid action. Common types mainly include: TCM compound preparations, such as Compound Danshen Tablets (for promoting blood circulation and removing blood stasis); and TCM-Western medicine compound preparations, such as Compound Licorice Tablets (containing licorice fluid extract and opium powder), etc. Their dosage form characteristics are mainly reflected in rapid action and multi-target regulation.

[0003] Regarding rapid efficacy, the onset time can be shortened by optimizing the process (such as drop pills or sublingual administration), such as the quick-acting heart-saving pill (sublingual administration);

[0004] In terms of multi-target regulation, the compound components work synergistically on multiple pathological processes.

[0005] The principle behind this type of fast-acting compound traditional Chinese medicine preparation is as follows:

[0006] Synergistic effect: Different components in a compound medicine enhance the therapeutic effect through complementary effects (such as the synergistic antitussive effect of licorice and opium in compound licorice tablets);

[0007] Toxicity reduction effect: Some components can reduce the toxicity of other drugs (e.g., Scutellaria baicalensis in Huanglian Jiedu Decoction reduces the cold nature of Coptis chinensis).

[0008] However, in the existing technology, due to the failure to fully utilize the synergistic effect of the components in the selection of compounding, there are certain shortcomings in safety and rapid solubility, and the full effect cannot be achieved. Summary of the Invention

[0009] The purpose of this invention is to provide a fast-acting compound preparation of traditional Chinese medicine and its preparation method, which has the characteristics of rapid solubility, good safety and good efficacy.

[0010] This invention can be achieved through the following technical solutions:

[0011] The present invention comprises a fast-acting compound preparation of traditional Chinese medicine, comprising the following parts by weight: 25-35 parts of Cordyceps militaris active peptide, 15-25 parts of American ginseng saponin extract, 10-20 parts of grape seed proanthocyanidin extract, 15-20 parts of Polygonatum sibiricum extract, 8-12 parts of Lycium barbarum polysaccharide extract, and 5-8 parts of leek seed volatile oil.

[0012] This formulation composition can simultaneously act on the nitric oxide-cyclic guanosine monophosphate (NO-cGMP) pathway, the adenosine monophosphate-activated protein kinase (AMPK) pathway, and the hypothalamic-pituitary-adrenal (HPA) axis in the human body, achieving rapid multi-target regulation. This fast-acting traditional Chinese medicine compound formulation composition can be used as a drug or health food for rapidly relieving cardiovascular and cerebrovascular discomfort, improving microcirculation, combating fatigue, or enhancing immunity. Specifically, the formulation takes effect within 15-30 minutes after oral administration.

[0013] Furthermore, this Cordyceps militaris active peptide is produced by degrading the macromolecular protein of Cordyceps militaris into small molecule active peptides with a molecular weight of less than 1000 Da through enzymatic biotransformation technology.

[0014] Furthermore, the Polygonatum extract is obtained by nano-pulverization or nano-emulsification technology, with a particle size distribution between 50-500 nanometers, and its main active ingredients include Polygonatum polysaccharides and Polygonatum saponins.

[0015] Furthermore, the dosage form of the pharmaceutical composition is an oral dosage form, which may be a capsule, tablet, pellet, or oral liquid.

[0016] Another aspect of the present invention relates to a method for preparing the above-mentioned fast-acting compound traditional Chinese medicine preparation, comprising the following steps:

[0017] S1. Enzymatic hydrolysis and purification of Cordyceps militaris active peptides: Cordyceps militaris raw material is subjected to enzymatic hydrolysis and biotransformation, and after enzyme inactivation, it is separated and purified to obtain Cordyceps militaris active peptides.

[0018] S2. Extraction of Polygonatum extract: Nano-extraction treatment of Polygonatum raw material to obtain nano-sized Polygonatum extract;

[0019] S3. Preparation of other components: High-purity American ginseng saponin extract, grape seed proanthocyanidin extract, wolfberry polysaccharide extract and leek seed volatile oil were prepared respectively.

[0020] S4. Mixing and Formulation: The components obtained in steps S1-S3 are mixed together and then mixed with excipients to form the desired dosage form.

[0021] Furthermore, the dosage form of the formulation is a tablet, and its excipients are fillers, binders, disintegrants, and lubricants.

[0022] Furthermore, the dosage form of the formulation is a capsule, and its excipients are fillers, disintegrants, lubricants, and functional excipients.

[0023] Furthermore, the dosage form of the formulation is a drop pill, and its excipients are a matrix, a cooling agent, and functional excipients.

[0024] Furthermore, the dosage form of the formulation is an oral liquid, and its excipients are a basic solvent and functional excipients.

[0025] This invention discloses a fast-acting compound preparation of traditional Chinese medicine and its preparation method, which has the following beneficial effects:

[0026] The formulation of the present invention is compounded with preferred components and achieves rapid onset of action within 15-30 minutes. It combines the rapid effect of Western medicine with the safety and multi-target conditioning advantages of traditional Chinese medicine and can be used to quickly improve circulation, fight fatigue and enhance immunity. Detailed Implementation

[0027] To enable those skilled in the art to better understand the technical solution of the present invention, the product of the present invention will be further described in detail below with reference to embodiments.

[0028] The present invention comprises a fast-acting compound preparation of traditional Chinese medicine, comprising the following parts by weight: 25-35 parts of Cordyceps militaris active peptide, 15-25 parts of American ginseng saponin extract, 10-20 parts of grape seed proanthocyanidin extract, 15-20 parts of Polygonatum sibiricum extract, 8-12 parts of Lycium barbarum polysaccharide extract, and 5-8 parts of leek seed volatile oil.

[0029] Furthermore, this Cordyceps militaris active peptide is produced by degrading the macromolecular protein of Cordyceps militaris into small molecule active peptides with a molecular weight of less than 1000 Da through enzymatic biotransformation technology.

[0030] Furthermore, the Polygonatum extract was obtained by nano-pulverization or nano-emulsification technology, and its particle size distribution is between 50-500 nanometers.

[0031] Furthermore, the dosage form of the pharmaceutical composition is an oral dosage form, which may be a capsule, tablet, pellet, or oral liquid.

[0032] Another aspect of the present invention relates to a method for preparing the above-mentioned fast-acting compound traditional Chinese medicine preparation, comprising the following steps:

[0033] S1. Enzymatic hydrolysis and purification of Cordyceps militaris active peptides: Cordyceps militaris raw material is subjected to enzymatic hydrolysis and biotransformation, and after enzyme inactivation, it is separated and purified to obtain Cordyceps militaris active peptides.

[0034] S2. Extraction of Polygonatum extract: Nano-extraction treatment of Polygonatum raw material to obtain nano-sized Polygonatum extract;

[0035] S3. Preparation of other components: High-purity American ginseng saponin extract, grape seed proanthocyanidin extract, wolfberry polysaccharide extract and leek seed volatile oil were prepared respectively.

[0036] S4. Mixing and Formulation: The components obtained in steps S1-S3 are mixed together and then mixed with excipients to form the desired dosage form.

[0037] Furthermore, the dosage form of the formulation is a tablet, and its excipients are fillers, binders, disintegrants, and lubricants.

[0038] Furthermore, the dosage form of the formulation is a capsule, and its excipients are fillers, disintegrants, lubricants, and functional excipients.

[0039] Furthermore, the dosage form of the formulation is a drop pill, and its excipients are a matrix, a cooling agent, and functional excipients.

[0040] Furthermore, the dosage form of the formulation is an oral liquid, and its excipients are a basic solvent and functional excipients.

[0041] Example 1

[0042] This embodiment relates to a fast-acting compound preparation of traditional Chinese medicine, comprising the following parts by weight: 35 parts of Cordyceps militaris active peptide, 20 parts of American ginseng saponin extract, 10 parts of grape seed proanthocyanidin extract, 20 parts of Polygonatum sibiricum extract, 10 parts of Lycium barbarum polysaccharide extract, and 5 parts of leek seed volatile oil.

[0043] In this embodiment, the Cordyceps militaris active peptide is obtained by enzymatic biotransformation technology to degrade the macromolecular protein of Cordyceps militaris into small molecule active peptides with a molecular weight of less than 1000 Da; the Polygonatum extract is obtained by nano-pulverization or nano-emulsification technology, and its particle size distribution is between 50-500 nanometers.

[0044] The preparation method of this fast-acting compound traditional Chinese medicine preparation includes the following steps:

[0045] S1. Enzymatic hydrolysis and purification of Cordyceps militaris active peptides: Cordyceps militaris raw material is subjected to enzymatic hydrolysis and biotransformation, and after enzyme inactivation, it is separated and purified to obtain Cordyceps militaris active peptides.

[0046] S2. Extraction of Polygonatum extract: Nano-extraction treatment of Polygonatum raw material to obtain nano-sized Polygonatum extract;

[0047] S3. Preparation of other components: High-purity American ginseng saponin extract, grape seed proanthocyanidin extract, wolfberry polysaccharide extract and leek seed volatile oil were prepared respectively.

[0048] S4. Mixing and Formulation: The components obtained in steps S1-S3 are mixed together and then mixed with excipients to form the desired dosage form.

[0049] In terms of specific dosage form, the dosage form of this formulation is an oral liquid, and its excipients are basic solvent and functional excipients.

[0050] Example 2

[0051] This embodiment relates to a fast-acting compound preparation of traditional Chinese medicine, comprising the following parts by weight: 30 parts of Cordyceps militaris active peptide, 15 parts of American ginseng saponin extract, 20 parts of grape seed proanthocyanidin extract, 17 parts of Polygonatum sibiricum extract, 8 parts of Lycium barbarum polysaccharide extract, and 8 parts of leek seed volatile oil.

[0052] In this embodiment, the Cordyceps militaris active peptide is obtained by enzymatic biotransformation technology to degrade the macromolecular protein of Cordyceps militaris into small molecule active peptides with a molecular weight of less than 1000 Da; the Polygonatum extract is obtained by nano-pulverization or nano-emulsification technology, and its particle size distribution is between 50-500 nanometers.

[0053] The preparation method of this fast-acting compound traditional Chinese medicine preparation includes the following steps:

[0054] S1. Enzymatic hydrolysis and purification of Cordyceps militaris active peptides: Cordyceps militaris raw material is subjected to enzymatic hydrolysis and biotransformation, and after enzyme inactivation, it is separated and purified to obtain Cordyceps militaris active peptides.

[0055] S2. Extraction of Polygonatum extract: Nano-extraction treatment of Polygonatum raw material to obtain nano-sized Polygonatum extract;

[0056] S3. Preparation of other components: High-purity American ginseng saponin extract, grape seed proanthocyanidin extract, wolfberry polysaccharide extract and leek seed volatile oil were prepared respectively.

[0057] S4. Mixing and Formulation: The components obtained in steps S1-S3 are mixed together and then mixed with excipients to form the desired dosage form.

[0058] Regarding the specific dosage form, the dosage form of this pharmaceutical composition is an oral capsule, and its excipients are fillers, binders, disintegrants and lubricants.

[0059] Example 3

[0060] This embodiment relates to a fast-acting compound preparation of traditional Chinese medicine, comprising the following parts by weight: 25 parts of Cordyceps militaris active peptide, 25 parts of American ginseng saponin extract, 15 parts of grape seed proanthocyanidin extract, 15 parts of Polygonatum sibiricum extract, 12 parts of Lycium barbarum polysaccharide extract, and 6 parts of leek seed volatile oil.

[0061] In this embodiment, the Cordyceps militaris active peptide is obtained by enzymatic biotransformation technology to degrade the macromolecular protein of Cordyceps militaris into small molecule active peptides with a molecular weight of less than 1000 Da; the Polygonatum extract is obtained by nano-pulverization or nano-emulsification technology, and its particle size distribution is between 50-500 nanometers.

[0062] The preparation method of this fast-acting compound traditional Chinese medicine preparation includes the following steps:

[0063] S1. Enzymatic hydrolysis and purification of Cordyceps militaris active peptides: Cordyceps militaris raw material is subjected to enzymatic hydrolysis and biotransformation, and after enzyme inactivation, it is separated and purified to obtain Cordyceps militaris active peptides.

[0064] S2. Extraction of Polygonatum extract: Nano-extraction treatment of Polygonatum raw material to obtain nano-sized Polygonatum extract;

[0065] S3. Preparation of other components: High-purity American ginseng saponin extract, grape seed proanthocyanidin extract, wolfberry polysaccharide extract and leek seed volatile oil were prepared respectively.

[0066] S4. Mixing and Formulation: The components obtained in steps S1-S3 are mixed together and then mixed with excipients to form the desired dosage form.

[0067] In terms of specific dosage form, the dosage form of this pharmaceutical composition is an oral dosage form, which is a capsule, and its excipients are fillers, disintegrants, lubricants, and functional excipients.

[0068] Example 4

[0069] This embodiment relates to a fast-acting compound preparation of traditional Chinese medicine, comprising the following parts by weight: 28 parts of Cordyceps militaris active peptide, 23 parts of American ginseng saponin extract, 13 parts of grape seed proanthocyanidin extract, 18 parts of Polygonatum sibiricum extract, 9 parts of Lycium barbarum polysaccharide extract, and 7 parts of leek seed volatile oil.

[0070] In this embodiment, the Cordyceps militaris active peptide is obtained by enzymatic biotransformation technology to degrade the macromolecular protein of Cordyceps militaris into small molecule active peptides with a molecular weight of less than 1000 Da; the Polygonatum extract is obtained by nano-pulverization or nano-emulsification technology, and its particle size distribution is between 50-500 nanometers.

[0071] The preparation method of this fast-acting compound traditional Chinese medicine preparation includes the following steps:

[0072] S1. Enzymatic hydrolysis and purification of Cordyceps militaris active peptides: Cordyceps militaris raw material is subjected to enzymatic hydrolysis and biotransformation, and after enzyme inactivation, it is separated and purified to obtain Cordyceps militaris active peptides.

[0073] S2. Extraction of Polygonatum extract: Nano-extraction treatment of Polygonatum raw material to obtain nano-sized Polygonatum extract;

[0074] S3. Preparation of other components: High-purity American ginseng saponin extract, grape seed proanthocyanidin extract, wolfberry polysaccharide extract and leek seed volatile oil were prepared respectively.

[0075] S4. Mixing and Formulation: The components obtained in steps S1-S3 are mixed together and then mixed with excipients to form the desired dosage form.

[0076] In terms of specific dosage form, the dosage form of this pharmaceutical composition is an oral dosage form, which is a drop pill, and its excipients are a matrix, a cooling agent, and functional excipients.

[0077] In this invention, unless otherwise explicitly specified and limited, the terms "installation," "connection," "linking," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0078] The above embodiments are merely specific examples of the present invention, and their descriptions are quite specific and detailed, but they should not be construed as limiting the scope of the present invention. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these obvious substitutions all fall within the protection scope of the present invention.

Claims

1. A fast-acting compound preparation of traditional Chinese medicine, characterized in that... It includes the following components by weight: 25-35 parts of Cordyceps militaris active peptides, 15-25 parts of American ginseng saponin extract, 10-20 parts of grape seed proanthocyanidin extract, 15-20 parts of Polygonatum sibiricum extract, 8-12 parts of Lycium barbarum polysaccharide extract, and 5-8 parts of leek seed volatile oil.

2. The fast-acting compound traditional Chinese medicine preparation composition according to claim 1, characterized in that: This Cordyceps militaris bioactive peptide is produced by enzymatic biotransformation technology, which degrades the macromolecular protein of Cordyceps militaris into small bioactive peptides with a molecular weight of less than 1000 Da.

3. The fast-acting compound traditional Chinese medicine preparation composition according to claim 1, characterized in that: The Polygonatum extract was obtained by nano-pulverization or nano-emulsification technology, and its particle size distribution is between 50-500 nanometers.

4. The fast-acting compound traditional Chinese medicine preparation composition according to claim 1, characterized in that: The dosage form of the pharmaceutical composition is an oral dosage form, which may be a capsule, tablet, drop pill, or oral liquid.

5. A method for preparing a fast-acting compound traditional Chinese medicine preparation composition according to any one of claims 1-4, characterized in that... Includes the following steps: S1. Enzymatic hydrolysis and purification of Cordyceps militaris active peptides: Cordyceps militaris raw material is subjected to enzymatic biotransformation, and after enzyme inactivation, it is separated and purified to obtain Cordyceps militaris active peptides; S2. Extraction of Polygonatum sibiricum extract: Polygonatum sibiricum raw material is subjected to nano-extraction treatment to obtain nano-sized Polygonatum sibiricum extract; S3. Preparation of other components: High-purity American ginseng saponin extract, grape seed proanthocyanidin extract, wolfberry polysaccharide extract and leek seed volatile oil are prepared respectively; S4. Mixing and formulation: The components obtained in steps S1-S3 are compounded and mixed with excipients to prepare the desired dosage form.

6. The method for preparing the fast-acting compound traditional Chinese medicine preparation composition according to claim 5, characterized in that: The dosage form of this formulation is a tablet, and its excipients are fillers, binders, disintegrants and lubricants.

7. The method for preparing the fast-acting compound traditional Chinese medicine preparation composition according to claim 5, characterized in that: The dosage form of this formulation is a capsule, and its excipients include fillers, disintegrants, lubricants, and functional excipients.

8. The method for preparing the fast-acting compound traditional Chinese medicine preparation composition according to claim 5, characterized in that: The dosage form of this formulation is drop pills, and its excipients are matrix, cooling agent, and functional excipients.

9. The method for preparing the fast-acting compound traditional Chinese medicine preparation composition according to claim 5, characterized in that: The dosage form of this pharmaceutical composition is an oral liquid, and its excipients are a basic solvent and functional excipients.